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FDA NDA · NDA205004

BORTEZOMIB

Sponsor: FRESENIUS KABI USA

APPLICATION
NDA205004
TYPE
NDA
ORIGINAL APPROVAL
2017-11-06
LATEST ACTION
2021-09-20
ROUTE
INTRAVENOUS
DOSAGE FORM
POWDER
MARKETING STATUS
Discontinued

Products

BORTEZOMIBDiscontinued
BORTEZOMIB 3.5MG/VIAL · POWDER · INTRAVENOUS

Approval history

2021-09-20Efficacy · Supplement 3 · standard — Label ↗AP
2018-07-12Labeling · Supplement 2 · standard — Label ↗AP
2017-11-06Type 5 - New Formulation or New Manufacturer · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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